2013-08-06 15:02:03 -
Innovative Design Enhancements Provide Patients Unprecedented Access to
MINNEAPOLIS - August 6, 2013 - With the first U.S. implants of its new
RestoreSensor(®) SureScan(®) MRI neurostimulation systems, Medtronic, Inc.
(NYSE: MDT) is introducing the first and only implantable neurostimulation (also
known as spinal cord stimulation, or SCS) systems for use in the treatment of
chronic, intractable back and/or limb pain that are approved by the U.S. Food
and Drug Administration (FDA) for conditionally safe* full-body Magnetic
Resonance Imaging (MRI) under specific conditions.
MRI scans have become a diagnostic standard of care, allowing physicians to
wide range of health conditions by viewing highly detailed images of
internal organs, blood vessels, muscle, joints, tumors, areas of infection and
other areas of the body by using strong magnetic fields and radio frequency
pulses to create images of structures inside the body. As advancements in
technology have increased accuracy, effectiveness and patient comfort, MRI use
has grown dramatically in recent years. Worldwide, it is estimated that 60
million MRI procedures are performed each year.(1) In the United States, the
number of scans has nearly doubled in the past decade, with 32 million scans -
more than one MRI per second -- performed in 2011.(2)
Until now, SCS patients referred for a body MRI were denied a scan due to
concerns about the system being affected by the large magnetic fields and radio
frequency (RF) energy involved in MRI. Medtronic's neurostimulation systems with
SureScan MRI technology and Vectris(®) SureScan(®) MRI percutaneous leads are
specially designed with enhancements to reduce or eliminate the hazards produced
by the MRI environment. The systems also include a proprietary SureScan feature,
which sets the neurostimulator into an appropriate mode for the MRI environment,
enabling the radiology departments to easily and conveniently confirm a
patient's implantable system is safe for MRI scanning.
Among the first physicians to implant these new systems are neurosurgeon Ali
Rezai, M.D., professor and director of the Center for Neuromodulation and
Functional Neurosurgery at The Ohio State University Wexner Medical Center in
Columbus, Ohio, and president of both the North American Neuromodulation Society
and Congress of Neurological Surgeons; David L. Caraway, M.D., Ph.D., medical
director for St. Mary's Pain Relief Center in Huntington, W.Va., and a member of
the board of directors for the North American Neuromodulation Society and
executive vice president, American Society of Interventional Pain Physicians;
and Mehul J. Desai, M.D., M.P.H., director, spine, pain medicine and research at
Metro Orthopedics and Sports Therapy (MOST) in Silver Spring, Md.
"The ability to safely perform MRI scans after a spinal cord stimulator implant
(SCS) is an important advance and a major benefit for our patients," said Dr.
Rezai. "In today's medical practice, MRI examinations are necessary and
routinely performed for diagnosis and clinical care. It is very likely that a
patient with chronic pain, spinal disease, neurological and orthopedic disorders
will require an MRI scan. However, until now, this was not feasible with SCS
implants. I am happy that we will now be able to offer MRI scans for our
The RestoreSensor SureScan MRI neurostimulation system is one of a portfolio of
new Medtronic neurostimulation systems enhanced with this technology and using
Vectris(®) SureScan(®) MRI leads, which include: PrimeAdvanced(®) SureScan MRI,
RestoreAdvanced(®) SureScan MRI, and RestoreUltra(®) SureScan MRI. The systems
received FDA approval in March 2013 and Conformité Européenne (CE) Mark approval
in January 2013.
"The approval of Medtronic's SureScan neurostimulation systems means patients
finding relief from their chronic pain with neurostimulation therapy can feel
confident knowing they have access to an important diagnostic tool without
compromising their healthcare," said Julie Foster, general manager and vice
president, Pain Stimulation and Targeted Drug Delivery in the Neuromodulation
business of Medtronic, Inc. "This latest innovation is yet another example of
our ongoing commitment to provide clinicians with safe, effective solutions to
meet the needs of their patients."
Medtronic SureScan neurostimulation systems with Vectris SureScan percutaneous
MRI leads for chronic pain are the latest additions to a growing number of
existing Medtronic devices that are designed for MRI access. These include the
Medtronic SynchroMed(®) II programmable drug infusion system and Medtronic
SureScan(® )pacing systems, which are available worldwide.
A multimedia version of this release, with links to graphics, animation and
additional background information can be found at: bit.ly/16WTXwu
About Medtronic Neurostimulation Therapy for Chronic Pain
Medtronic neurostimulation therapy for chronic pain uses a medical device placed
under a patient's skin to deliver mild electrical impulses to the spinal cord,
which act to block pain signals from going to the brain. Since Medtronic
developed the therapy in partnership with physicians in the 1980s, Medtronic
neurostimulation therapy has helped nearly 200,000 people worldwide manage their
chronic pain and enhance their lives. In 2011, the FDA approved Medtronic's
AdaptiveStim(®) with RestoreSensor(®), the first neurostimulator to incorporate
motion sensor technology to help treat chronic pain. The innovative system uses
a proprietary sensor and algorithm to automatically detect and respond to
changes in the patient's body position, resulting in effective pain relief and
convenience. More information about Medtronic's SureScan MRI Technology for
spinal cord stimulation can be found at: www.mrisurescan.com.
Medtronic's Leadership in Neuromodulation
Medtronic developed and leads the field of neuromodulation, the targeted and
regulated delivery of electrical pulses and pharmaceuticals to specific sites in
the nervous system. The company's Neuromodulation business includes implantable
neurostimulation and targeted drug delivery systems for the management of
chronic pain, common movement disorders, spasticity and urologic and
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, Minnesota, is
the global leader in medical technology - alleviating pain, restoring health,
and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
- end -
* Under specific conditions. Refer to approved labeling.
(1) Sutton R, Kanal E, Wilkoff BL, Bello D, et al. Safety of magnetic resonance
imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system:
clinical study design. Trials 2008, 9:68.
(2) IMV Benchmark Report 2012. IMV Medical Information Division. Des Plaines,
Illinois. Page 1.
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Source: Medtronic, Inc. via Thomson Reuters ONE